← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

OTE — Digital Breast Tomosynthesis

To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES

Recent clearances

P140011Siemens Medical Solutions USA, Inc. · pma2026-07-01
P080003Hologic, Inc. · pma2025-11-24
P130020GE Healthcare · pma2025-11-21

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →